Project Summary According to the National Cancer Institute, about 50,000 people in the US will be newly diagnosed with oral cancer (OC) in 2018, causing over 9,700 deaths. OC is a severely neglected orphan disease with a lack of significant treatment advances in 4 decades and about 64% of patients die within the first 5 years of diagnosis. Historically, OC has been present in heavy smokers and drinkers. However, more recently OC has also become more prevalent in younger people due to an increase in cancer-causing human papillomavirus (HPV) spread through oral sex. The current standard of care (SOC) for patients with early stage disease is surgical intervention. However, this can result in disfiguring side effects that impair oral form and function such as the ability to speak and swallow. Surgical treatment of OC also has an exceptionally high rate of recurrence, due in part to tumor margins which are difficult to identify or access. To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, PRV111 that is applied directly to the tumor. PRV111 consists of a mucoadhesive polymeric patch with embedded cisplatin-loaded particles (CPs) and a non-permeable backing that facilitates unidirectional drug release, prevents drug loss, and masks taste. Cisplatin is recognized as the gold standard chemotherapeutic for treating oral cancer. However, cisplatin?s efficacy is often hindered by significant systemic toxicity resulting from traditional systemic intravenous (IV) administration. CP?s have optimized size, charge, and permeation parameters to ensure that cisplatin is locally retained within the tumor tissue and not exposed to systemic bodily circulation. Privo has performed 12 sets of in vivo studies in 5 species of animals to examine the safety and efficacy of PRV111. In all cases, PRV111 has shown robust antitumor effect and no local or systemic toxicities. The goal of this proposal is the successful completion of Privo?s clinical trial. The results of this study will be published to share its findings with the scientific and medical community. Privo is confident that its team of expert scientists, business leaders, and collaborators can execute its defined aims with milestones and deliverables.